Toxicity Due to ChemotherapyNCT02848807
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
A study testing NUTRIDRINK Compact Protein in people with Toxicity Due to Chemotherapy and Cancer Cachexia, run by University Clinical Centre, Gdansk at 1 site in Poland.
Trial summary
Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toxicity Due to Chemotherapy, Cancer Cachexia, Metastatic Colorectal Cancer
- What is being tested?
- NUTRIDRINK Compact Protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological confirmed diagnosis of CRC in clinical stage IV
- successful qualification to chemotherapy
- performance status at least 80% according to Karnofsky scale and <2 according to WHO/ECOG scale
- cancer-related asymptomatic precachexia diagnosed
- absence of contraindications to oral nutrition and practicable realization of oral nutrition
- absence of severe, decompensated concomitant diseases
- signed informed consent for the participation in the study
Who cannot join
- diagnosis of a malignant neoplasm in clinical stage I-III
- disqualification from oncologic treatment
- cancer cachexia or cancer anorexia-cachexia syndrome
- poor performance status
- contraindications to oral nutrition or to high protein nutrition
- regular nutritional support at the moment of qualification to the study
- patient incompliance at the moment of qualification to the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Centre
Gdansk
Sylwia Malgorzewicz, MD, PhD, +48 58 3492724, sylwiam@gumed.edu.pl
Sylwia Malgorzewicz, MD, PhD
About this study
Official title: Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study
Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.
Read the detailed description
Other endpoints:
- to determine whether high protein ONS influence on the nutritional status
- to determine whether high protein ONS influence on the quality of life
- to determine whether high protein ONS influence on the performance status
- to determine high protein ONS tolerability / ONS intake compliance
- Conditions
- Toxicity Due to Chemotherapy, Cancer Cachexia, Metastatic Colorectal Cancer, Quality of Life, Dietary Modification
- Being tested
- NUTRIDRINK Compact Protein
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUTRIDRINK Compact ProteinDietary supplement
Also called Oral nutritional supplement
high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)
| Study group | Role | What they receive |
|---|---|---|
| NUTRIDRINK Compact Protein | Active comparator | NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice Receives: Dietary Supplement: NUTRIDRINK Compact Protein |
| without oral nutritional supplements | No intervention | Dietary advice alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy-related toxicity during 12th week of observation
graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0); to determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy during 3 months observation period (comparison of the results at the baseline and after 12 weeks)
Measured: at baseline and after 12th week
Secondary outcomes (3)
Changes in the Nutritional status / metabolic status
the assessment according to Nutritional Risk Screening 2002 (NRS 2002), Subjective Global Assessment (SGA), body mass, body mass index (BMI), VAS for appetite, albumin, prealbumin, triglycerides, total cholesterol, fasting blood glucose, C-reactive protein (CRP), ferritin, complete blood count.
Body mass (in kg) will measure by the scales (Tanita BC 420). Hight ( in cm) measure by Stadiometer (Tanita)
Body mass index calculation (BMI) on the basis of the following formula:
BMI = body weight / height2 (kg/m2).
VAS for appetite is 100-mm line where 0 mm means "I had no appetite at all" and 100 mm means "My appetite was very good".
Laboratory parameters will measured by routine laboratory methods. All results will be compared between study groups (ONS vs without ONS) at the same time point (eg. baseline group ONS vs baseline group without ONS)
Measured: at baseline and after 12th week
Changes in the Quality of life and patients well-being
FAACT-ESPEN score Version 4 (Functional Assessment of Anorexia/Cachexia Therapy questionnaire) is a measure of the quality of life and it is completed by a patient, it has a total of 42 questions. Patients mark 0 (none) - 4 (very much) for each question. This tool consists of five subscales: functional well-being (7 items), physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and other aspects, including appetite (13 items).
The maximum score is 168. The lower the score, the lower overall quality of life.
Measured: at baseline and after 12th week
Changes in the Performance status
To performance status assessment will be used Kornofsky scale and ECOG scale. The Karnofsky score allows to quantify the overall state and quality of life of a patient with neoplastic disease who qualifies to receive chemotherapy. The score has a range from 0 to 100, where 100 represents the ideal state and 0 - death.
The Eastern Cooperative Oncology Group(ECOG) score runs from 0 to 5, with 0 denoting perfect health and 5 death.
Measured: at baseline and after 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Toxicity Due to ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Centre, Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Foundation
- Responsible party
- Sponsor
- Investigators
- Sylwia Malgorzewicz, MD, PhD, Principal investigator, University Clinical Centre, Gdansk, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848807
- Sponsor's protocol ID
- 01/2014/UCK
- Status last verified
- Jul 2016
- First submitted
- 16 Jul 2014
- Last updated
- 29 Jul 2016
- Results posted
- No
- Individual data sharing
- Yes: publication in nutritional and oncological journals, presentation on the congresses
Publications
Zietarska M, Malgorzewicz S. Quality of Life of Colorectal Cancer Patients Treated with Chemotherapy. Nutrients. 2026 Jan 7;18(2):191. doi: 10.3390/nu18020191.
PubMed 41599804
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT02848807
- Acronym / sponsor ID
- 01/2014/UCK
- Conditions
- Toxicity Due to Chemotherapy, Cancer Cachexia, Metastatic Colorectal Cancer, Quality of Life, Dietary Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Clinical Centre, GdanskUniversity, hospital or other
- Collaborators
- Nutricia Foundation
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.
Detailed description
Other endpoints:
- to determine whether high protein ONS influence on the nutritional status
- to determine whether high protein ONS influence on the quality of life
- to determine whether high protein ONS influence on the performance status
- to determine high protein ONS tolerability / ONS intake compliance
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NUTRIDRINK Compact Protein | Active comparator | Dietary Supplement: NUTRIDRINK Compact ProteinNUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice |
| without oral nutritional supplements | No intervention | –Dietary advice alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- histological confirmed diagnosis of CRC in clinical stage IV
- successful qualification to chemotherapy
- performance status at least 80% according to Karnofsky scale and <2 according to WHO/ECOG scale
- cancer-related asymptomatic precachexia diagnosed
- absence of contraindications to oral nutrition and practicable realization of oral nutrition
Key exclusion criteria (7 listed)
- diagnosis of a malignant neoplasm in clinical stage I-III
- disqualification from oncologic treatment
- cancer cachexia or cancer anorexia-cachexia syndrome
- poor performance status
- contraindications to oral nutrition or to high protein nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUTRIDRINK Compact ProteinAlso: Oral nutritional supplementhigh-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months) | Dietary supplement | NUTRIDRINK Compact Protein |
Primary outcome
Chemotherapy-related toxicity during 12th week of observation
Time frame: at baseline and after 12th week
graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0); to determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy during 3 months observation period (comparison of the results at the baseline and after 12 weeks)
3 secondary outcomes
Changes in the Nutritional status / metabolic status
Time frame: at baseline and after 12th week
Changes in the Quality of life and patients well-being
Time frame: at baseline and after 12th week
Changes in the Performance status
Time frame: at baseline and after 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 41599804Zietarska M, Malgorzewicz S. Quality of Life of Colorectal Cancer Patients Treated with Chemotherapy. Nutrients. 2026 Jan 7;18(2):191. doi: 10.3390/nu18020191.
- Individual participant dataSharing planned: Yes. publication in nutritional and oncological journals, presentation on the congresses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylwia Malgorzewicz, MD, PhD principal investigator
University Clinical Centre, Gdansk, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTRIDRINK Compact Protein in people with Toxicity Due to Chemotherapy and Cancer Cachexia, run by University Clinical Centre, Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylwia Malgorzewicz, MD, PhD (+48 58 3492724, sylwiam@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-related toxicity during 12th week of observation (time frame: at baseline and after 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.